Cobra offers a full range of analytical packages and stand-alone services that are capable of supporting all phases of biopharmaceutical development. The analytical services include industry standard methods as well as high-end mass spectrometry and physicochemical characterisation according to ICH Q6B. All analytical processes and instruments are maintained at appropriate levels with respect to cGMP and regulatory requirements.
Cobra is able to provide a number of analytical packages, with product characterisation available from initial to late stage development, together with the establishment of analytical reference standards for any development phase..
We provide QC release testing of Drug Substance and Drug Product with QA approved Certificate of Analysis for CMC documentation support, including support for setting and justification of Drug Substance and Drug Product specifications. Physicochemical characterisation and comparability according to Q6B can be offered as well as batch release and (re)testing for European markets.
Shipping studies to determine stability for product transportation, including variations in temperature, humidity, light and oxygen levels can be undertaken, as required.
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